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Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
pemetrexed disodium
adjuvant therapy
therapeutic conventional surgery
fludeoxyglucose F 18
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IB, II, IIIA, or IIIB (T4, N0-1) disease Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI Measurable and resectable disease T4 lesions must be resectable Eligible for curative surgery No malignant pleural effusion PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,250/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 3.0 times ULN Renal Creatinine clearance ≥ 45 mL/min Pulmonary Adequate pulmonary reserve to undergo surgery Predicted FEV_1 > 0.8 L after resection Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Able to take corticosteroids Able to take folic acid or vitamin B_12 supplements No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No concurrent serious or uncontrolled disorder that would preclude study participation No type I diabetes mellitus Type II diabetes mellitus allowed if glucose is 80-150 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent prophylactic filgrastim (G-CSF) No concurrent thrombopoiesis-stimulating agents Chemotherapy At least 5 years since prior chemotherapy Endocrine therapy No concurrent anticancer hormonal therapy Radiotherapy No prior radiotherapy to the chest No concurrent curative or palliative radiotherapy Surgery Not specified Other At least 30 days since prior non-FDA-approved or investigational agents At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam]) No other concurrent anticancer therapy No other concurrent investigational agents

Sites / Locations

  • Seattle Cancer Care Alliance
  • University of Washington School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant therapy, PET scan and surgery

Arm Description

Outcomes

Primary Outcome Measures

Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

Secondary Outcome Measures

Safety of Neoadjuvant Chemotherapy
The number of patients that experienced a grade 3 or higher adverse event.
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate
The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Full Information

First Posted
September 26, 2005
Last Updated
March 31, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00227539
Brief Title
Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Official Title
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.
Detailed Description
OBJECTIVES: Primary Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC). Secondary Determine the safety of cisplatin and pemetrexed disodium in these patients. Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium. OUTLINE: This is a multicenter study. Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor. Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant therapy, PET scan and surgery
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Primary Outcome Measure Information:
Title
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Description
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Time Frame
Between days 18 and 22 prior to second chemotherapy infusion
Secondary Outcome Measure Information:
Title
Safety of Neoadjuvant Chemotherapy
Description
The number of patients that experienced a grade 3 or higher adverse event.
Time Frame
Up to 4 weeks after last dose of chemotherapy
Title
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate
Description
The number of patients that had either a CR, PR or SD after the completion of chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
Time Frame
Up to 4 weeks after last dose of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IB, II, IIIA, or IIIB (T4, N0-1) disease Staging must have been performed 4 weeks prior to study entry with a CT scan of chest, upper abdomen, and fludeoxyglucose F 18 (^18FDG) positron emission tomography (PET) scan Mediastinal evaluation and staging based on combination of CT scan and FDG-PET results If N1 or N2 nodes are found by FDG-PET or CT scan, metastases must be ruled out by brain MRI Measurable and resectable disease T4 lesions must be resectable Eligible for curative surgery No malignant pleural effusion PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,250/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 3.0 times ULN Renal Creatinine clearance ≥ 45 mL/min Pulmonary Adequate pulmonary reserve to undergo surgery Predicted FEV_1 > 0.8 L after resection Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after completion of study treatment Able to take corticosteroids Able to take folic acid or vitamin B_12 supplements No other malignancy within the past 5 years except nonmelanoma skin cancer or noninvasive cervical cancer No concurrent serious or uncontrolled disorder that would preclude study participation No type I diabetes mellitus Type II diabetes mellitus allowed if glucose is 80-150 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy No concurrent prophylactic filgrastim (G-CSF) No concurrent thrombopoiesis-stimulating agents Chemotherapy At least 5 years since prior chemotherapy Endocrine therapy No concurrent anticancer hormonal therapy Radiotherapy No prior radiotherapy to the chest No concurrent curative or palliative radiotherapy Surgery Not specified Other At least 30 days since prior non-FDA-approved or investigational agents At least 5 days since prior aspirin or other nonsteroidal anti-inflammatory agents (8 days for long-acting agents [e.g., piroxicam]) No other concurrent anticancer therapy No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Martins, MD, MPH
Organizational Affiliation
Seattle Cancer Care Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30642285
Citation
Romine PE, Martins RG, Eaton KD, Wood DE, Behnia F, Goulart BHL, Mulligan MS, Wallace SG, Kell E, Bauman JE, Patel SA, Vesselle HJ. Long term follow-up of neoadjuvant chemotherapy for non-small cell lung cancer (NSCLC) investigating early positron emission tomography (PET) scan as a predictor of outcome. BMC Cancer. 2019 Jan 14;19(1):70. doi: 10.1186/s12885-019-5284-2.
Results Reference
derived

Learn more about this trial

Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

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